MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-10-17 for SPIDER SURGICAL PLATFORM 9000020 G2L 9000041 manufactured by Transenterix, Inc..
[2229331]
During a laparoscopic gastric band procedure, a retraction sheath was torn apart. It is noted that the device was used incorrectly, outside the labeled instructions for use. The surgeon elected to use the retraction sheath as an introduction sheath. Investigation has indicated that the surgeon purposefully chose to use the retraction sheath for insertion. The surgeon was able to retrieve the torn sheath and all parts were accounted for. No injury or impact to the patient was reported.
Patient Sequence No: 1, Text Type: D, B5
[9389319]
The investigation performed was intended to evaluate the manufacturing process for defects and attempt to recreate the failure. First the company qa unit reviewed and witnessed the manufacturing process to evaluate whether defects might have been introduced into the sheath. Other sheath inventory was checked for possible defects to attempt to identify a root cause. No cause for the failure mode related to manufacturing could be identified. Because the device ws not returned and the description of the failure mode was so unusual, the company attempted to 'recreate' the failure mode by repeating the steps used by the surgeon as recounted by the surgical sales rep. The actual failure could not be reproduced. There have never been any other similar failures either within verification and validation testing or from other customer complaints. It is surmised that the surgeon 'rolled up' the sheath within a separate trocar and then tried to push the spider device into the opening, possibly tangling the instrument delivery tubes within the sheath, thereby stretching and tearing the sheath.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007593944-2011-00008 |
| MDR Report Key | 2323082 |
| Report Source | 05 |
| Date Received | 2011-10-17 |
| Date of Report | 2011-10-18 |
| Date of Event | 2011-09-15 |
| Date Mfgr Received | 2011-09-15 |
| Device Manufacturer Date | 2011-07-01 |
| Date Added to Maude | 2012-07-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. TAMMY CARREA, VP |
| Manufacturer Street | 635 DAVIS DRIVE SUITE 300 |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9197658420 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPIDER SURGICAL PLATFORM |
| Generic Name | OTJ, LAPAROSCOPIC SINGLE PORT ACCESS |
| Product Code | OTJ |
| Date Received | 2011-10-17 |
| Model Number | 9000020 G2L |
| Catalog Number | 9000041 |
| Lot Number | TX195111 |
| ID Number | NA |
| Device Expiration Date | 2012-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TRANSENTERIX, INC. |
| Manufacturer Address | DURHAM NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-17 |